Table 1 Comparative methods and endpoints of the two supplementation studies
Study 1 [15] | Study 2 [16] | |
|---|---|---|
Methods | ||
Study design | Prospective, randomised, placebo-controlled trial | Prospective, randomised, placebo-controlled trial |
Stratification | None | Age (≥ or <50 years) Inhalation (yes/no) Burned BSA (≥ or <50%) |
Inclusion and exclusion criteria | Identical | Identical |
Trace elements per day (intravenous) | Copper 40.4 μmol (2.5 mg)/day Selenium 2.9 μmol (315 μg)/day Zinc 407 μmol (26.2 mg)/day | Copper 47.6 μmol (3.1 mg)/day Selenium 4.8 μmol (380 μg)/day Zinc 574 μmol (31.4 mg)/day |
Duration of supplementation | 8 days | 14 days if burns <60% of BSA 21 days if burns ≥60% of BSA |
Nutritional management | Early enteral feeding (within 12 hours of admission) targeted at 1.3 times of resting energy expenditure, reached during a period of 4 days | Identical |
Vitamins per day | Vitamin C 1 g, vitamin E 100 mg, vitamin B 100 mg, and multivitamin (Cernevit®; Baxter, Plessis, France) | Identical |
Blood sampling | Days 0, 1, 5, 10, 15, 20, and 30 for plasma trace elements + vitamin dosages | Identical + plasma GSHPx activity |
Skin biopsies | None | Days 3, 10, and 20: tissue selenium, zinc, and GSHPx activity |
Endpoints | ||
Clinical endpoints | Length of mechanical ventilation Length of ICU stay Length of ICU stay per burned percentage of BSA | Identical |
Wound healing | Success of skin grafting (percentage of grafted area per percentage of area with surgical burns) | Identical + Whole body turnover of glycerol, glucose, and phenylalanine Phenylalanine skin incorporation |
Immune response | Chemotaxis capacity of neutrophil T lymphocyte and neutrophil counts Cell surface markers on lymphocytes Adhesion molecules on neutrophils | Not performed |
Infectious complications and definition | Prospective surveillance during the first 30 days of stay according to predefined criteria [18] | Identical |
Antibiotic treatment | Details on antibiotic delivery (type, dose, and route) | Identical |